---
kind: "section"
citation: "21 C.F.R. § 808.55"
title: "21"
number: "808.55"
heading: "California."
url: "https://uscodex.org/cfr/21/808.55"
---

# §808.55. California.


The following California medical device requirements are preempted under [section 521(a)](/cfr/21/521.md?p=a) of the Federal Food, Drug, and Cosmetic Act, and FDA has denied them exemption from preemption:

- (a) **Medical devices; general provisions.** Sherman Food, Drug, and Cosmetic Law, Division 21 of the California Health and Safety Code, sections [26207](/cfr/21/26207.md), [26607](/cfr/21/26607.md), [26614](/cfr/21/26614.md), [26615](/cfr/21/26615.md), [26618](/cfr/21/26618.md), [26631](/cfr/21/26631.md), [26640](/cfr/21/26640.md), and [26441](/cfr/21/26441.md), to the extent that they apply to devices; and
- (b) **Ophthalmic devices; quality standards.** California Business and Professions Code, [section 2541.3](/cfr/21/2541.3.md) to the extent that it requires adoption of the American National Standards Institute standards Z-80.1 and Z-80.2.

## Notes

### Amendments

[87 FR 50762, Aug. 17, 2022]

### Authority

Authority: 21 U.S.C. 360j, 360k, 371. Section 808.1 also issued under Sec. 709, Public Law 115-52, 131 Stat. 1065-67.

### Source

Source: 43 FR 18665, May 2, 1978, unless otherwise noted.

### Amendments

[87 FR 50762, Aug. 17, 2022]